Zinger Key Points
- The formulated vaccine demonstrated comparable responses against SARS-CoV-2 versus the companies' licensed COVID-19 vaccine.
- The companies are evaluating adjustments to the combination vaccine candidate to improve immune responses against influenza B.
On Friday, Pfizer Inc. PFE and BioNTech SE BNTX released topline results from the Phase 3 trial of the combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age.
The combination candidate comprises Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine.
The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 and immunogenicity against influenza A and B), of which one was met.
Compared to a licensed influenza vaccine, the trivalent (tIRV) formulation demonstrated influenza A responses, including a continued trend of higher influenza A responses versus a licensed influenza vaccine, while it showed lower geometric mean titers and seroconversion (the time between exposure to a virus and when antibodies show up in the blood) against the influenza B strain.
In addition, the formulation demonstrated comparable responses against SARS-CoV-2 versus the companies’ licensed COVID-19 vaccine.
An ongoing safety data review has not identified any safety signals with the combination vaccine.
The companies are evaluating adjustments to the combination vaccine candidate to improve immune responses against influenza B and will discuss the next steps with health authorities.
The Phase 3 study enrolled 8,000 participants.
The setback comes after Moderna Inc. MRNA released positive Phase 3 trial data for its combination vaccine against Influenza and COVID-19 in June.
In a separate Phase 2 trial, Pfizer evaluated trivalent (tIRV) influenza mRNA standalone vaccine candidates, demonstrating robust immunogenicity in individuals aged 18 to 64.
Last year, Pfizer announced topline Phase 3 results from its first-generation quadrivalent (qIRV) vaccine candidate, which achieved the first and only demonstration of efficacy for an mRNA vaccine in a group of study participants aged 18- 64.
The primary endpoints for this first-generation candidate were not met in adults aged 65 and older, as statistical non-inferior relative vaccine efficacy compared to a licensed influenza vaccine was not met based on the number of cases accrued.
Pfizer developed second-generation candidates to improve immunogenicity.
The tIRV formulations elicited robust influenza A and B responses, including a continued trend of higher influenza A responses compared to a licensed influenza vaccine.
No safety signals were reported. Data from the Phase 2 trial for adults 65 and older will become available later.
Pfizer will also continue to evaluate its influenza vaccine program and discuss next steps with health authorities.
Price Action: BNTX stock is down 3.72% at $84.00, and PFE stock is down 0.03% at $28.70 during the premarket session at last check Friday.
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